Recalls / Class II
Class IID-0304-2021
Product
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
- Affected lot / code info
- Lot #: 148992, Exp 5/31/2022
Why it was recalled
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Recalling firm
- Firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, N/A, Burbank, California 91504-3425
Distribution
- Quantity
- 12 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-01-27
- FDA classified
- 2021-03-16
- Posted by FDA
- 2021-03-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0304-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.